United States Patent 9,415,016: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,415,016, titled "DPP-IV Inhibitor Combined with a Further Antidiabetic Agent, Tablets Comprising Such Formulations, Their Use and Process for Their Preparation," is a significant patent held by Boehringer Ingelheim International GmbH. This patent is crucial in the field of diabetes treatment, particularly for fixed-dose combination (FDC) therapies. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignee
The patent was invented by Thomas Friedl, Michael Braun, Kenji Egusa, Hikaru Fujita, Megumi Maruyama, and Takaaki Nishioka, and is assigned to Boehringer Ingelheim International GmbH, based in Ingelheim am Rhein, Germany[4].
Filing and Grant Dates
The patent application was filed on August 27, 2015, and granted on August 16, 2016. It is a continuation of earlier applications, including PCT/EP2009/053978 and provisional application No. 61/087,343[4].
Scope of the Invention
DPP-IV Inhibitors and Antidiabetic Agents
The patent pertains to oral solid dosage forms for a fixed-dose combination of a DPP-IV (dipeptidyl peptidase-IV) inhibitor and another antidiabetic agent. This combination is particularly useful for treating type 2 diabetes. The DPP-IV inhibitor, such as linagliptin, is combined with other antidiabetic agents like metformin, sulphonylureas, or insulin and insulin analogues[4].
Formulations and Preparation
The patent describes various formulations and the process for preparing these tablets. It includes details on the composition, dosage forms, and the manufacturing process to ensure the stability and efficacy of the combined therapy[4].
Claims Analysis
Independent and Dependent Claims
The patent includes multiple claims, both independent and dependent. Independent claims define the broad scope of the invention, while dependent claims add specific limitations to narrow down the scope. For example, Claim 1 describes the FDC of a DPP-IV inhibitor and another antidiabetic agent, while subsequent claims specify particular combinations, dosages, and formulations[4].
Claim Construction and Interpretation
The interpretation of claims is crucial for understanding the patent's scope. According to patent law, the specification of the patent must describe the claimed invention in "full, clear, concise, and exact terms" (35 U.S.C. § 112(a))[1]. The prosecution history of related patents, such as the '877 patent, provides additional context for claim construction, highlighting the importance of specific limitations and the absence of certain requirements, like dose adjustments[1].
Patent Landscape
Related Patents and Expiration Dates
The patent 9,415,016 is part of a larger portfolio of patents related to diabetes treatments held by Boehringer Ingelheim. Other relevant patents include U.S. Patent Nos. 8,551,957, 9,155,705, 9,949,998, 10,022,379, 10,258,637, and 10,406,172. These patents cover various aspects of the drug formulations and their use, with expiration dates ranging from 2025 to 2030[2][5].
Litigation and Infringement Claims
Boehringer Ingelheim has been involved in several litigation cases to protect its patents against generic manufacturers. For instance, the company has alleged infringement by Mylan and Lupin regarding the patents covering Trijardy XR, a drug that combines empagliflozin, linagliptin, and metformin hydrochloride[2][5].
Paragraph IV Certifications
Generic manufacturers often file ANDAs (Abbreviated New Drug Applications) with paragraph IV certifications, stating that the patents are invalid, unenforceable, or will not be infringed. This has led to legal disputes, such as the case where Mylan's ANDA included paragraph IV certifications for several patents, including the '927, '695, and '859 patents, which were later found invalid by the court[2].
Claim Coverage and Patent Analytics
Claim Coverage Matrix
To manage the complex landscape of patents and claims, companies use tools like the Claim Coverage Matrix. This matrix categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts. These charts help determine whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage is lacking and identifying future design opportunities[3].
Practical Implications
Protection of Intellectual Property
The patent 9,415,016 and its related patents are crucial for Boehringer Ingelheim's intellectual property protection in the diabetes treatment market. The company's efforts to enforce these patents against generic manufacturers ensure the exclusivity of their innovative treatments.
Innovation and Development
The detailed descriptions and claims in the patent encourage further innovation by providing a clear understanding of what is protected and what areas are open for new developments. This fosters a competitive environment where companies can innovate while respecting existing intellectual property rights.
Key Takeaways
- Scope and Claims: The patent covers FDCs of DPP-IV inhibitors and other antidiabetic agents, with specific claims detailing various combinations and formulations.
- Patent Landscape: The patent is part of a broader portfolio of related patents with varying expiration dates, and its enforcement is critical in protecting Boehringer Ingelheim's intellectual property.
- Litigation and Certifications: The patent has been involved in several legal disputes, including those related to paragraph IV certifications by generic manufacturers.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and analyzing the complex patent landscape.
FAQs
What is the main subject of United States Patent 9,415,016?
The main subject of United States Patent 9,415,016 is the fixed-dose combination of a DPP-IV inhibitor and another antidiabetic agent, specifically for treating type 2 diabetes.
Who is the assignee of this patent?
The assignee of this patent is Boehringer Ingelheim International GmbH.
What is the significance of the prosecution history in claim construction?
The prosecution history provides context for claim construction, helping to clarify specific limitations and the absence of certain requirements, such as dose adjustments.
How does Boehringer Ingelheim protect its intellectual property related to this patent?
Boehringer Ingelheim protects its intellectual property through litigation against generic manufacturers that allegedly infringe on its patents and by filing paragraph IV certifications.
What tools are used to manage and analyze the patent landscape?
Tools such as the Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® are used to manage and analyze the patent landscape.
Sources
- United States District Court for the Northern District of West Virginia. Boehringer Ingelheim Pharm., Inc. et al v. Mylan et al. [Online]. Available: https://www.govinfo.gov/content/pkg/USCOURTS-wvnd-1_20-cv-00019/pdf/USCOURTS-wvnd-1_20-cv-00019-0.pdf
- U.S. Food and Drug Administration. ANDA 208430 Tentative Approval. [Online]. Available: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208430Orig1s000TAltr.pdf
- Schwegman Lundberg & Woessner, P.A. Patent Analytics. [Online]. Available: https://www.slwip.com/services/patent-analytics/
- United States Patent and Trademark Office. U.S. Patent No. 9,415,016. [Online]. Available: https://patentimages.storage.googleapis.com/97/b6/1a/031f12060f6016/US9415016.pdf
- Law Street Media. Boehringer Ingelheim Pharmaceuticals Alleges Lupin Infringing on Patents for Trijardy XR. [Online]. Available: https://lawstreetmedia.com/news/health/boehringer-ingelheim-pharmaceuticals-alleges-lupin-infringing-on-patents-for-trijardy-xr/
